Theraflu Flu Relief Maximum Strength

Product NDC: 0067-8161
11-digit product format: 000678161
Labeler code: 0067
Product ID: 0067-8161_132b9415-743c-c981-e063-6394a90ae3de
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr and Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form: KIT
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-06-27
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Theraflu Flu Relief Maximum Strength
Brand name suffix: Daytime Nighttime Combo Pack
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
247324	Internal RxNorm lookup
1098496	Internal RxNorm lookup
2604579	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
68d3e88a-d1be-410b-92a1-863903b3aa61	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-8161-01	Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack	1 in 1 CARTON	KIT	1		3
0067-8162-01	Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack	20 in 1 BLISTER PACK	TABLET	20	15 mg	3
0067-8163-01	Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack	20 in 1 BLISTER PACK	TABLET	20	500 mg	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-8161	THERAFLU FLU RELIEF MAXIMUM STRENGTH DAYTIME NIGHTTIME COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC]	3	Current NDC, Legacy NDC, 3 package rows	20240310_68d3e88a-d1be-410b-92a1-863903b3aa61.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 32 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	14c56f3d-67fd-45ef-a16b-f27604722883	2026-05-12	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare, LLC.	51a4195b-8776-964c-e063-6294a90aa075	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ba3548e-85e7-b4a6-e063-6394a90af84d	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	fe7eeb71-e219-4c84-ac06-98c3a40b14dc	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	6f8241d7-0f30-40b3-926b-861c57079f1d	2026-05-12	Warnings	Exact identifier application number: M012
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51a45db8-2bee-6fd0-e063-6394a90ab587	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	19da539e-7b57-41d7-aad5-fc89a6705e20	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	182222b5-a852-4dbe-b05f-a41d89806021	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8a790eeb-7d7d-4a94-9103-6ed09c04d596	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	dbdafbb4-f3c9-4042-b867-db4d06dc3d61	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d03ef2fd-1a08-42c0-b69d-fd4e4285ccd3	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	29571047-4c4b-44ca-8726-57c28308e8cf	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	75c6b92f-219f-4740-bb72-c02a927a21ff	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	c746953f-4b7d-4e2a-9b85-96bd6901f517	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	cea08797-1d53-4434-be1a-144f2ded5f9d	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	2ef9d5de-e99e-4398-bf97-c7bef94498fa	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	a401eb92-60b6-427d-a677-29371a3150be	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ff4c4ea-7628-4d2b-a6e9-d994c25baef4	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d7c18e95-8d7b-4550-9a20-fc704a114adb	2026-05-12	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2604579	{1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) / 1 (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) } Pack	GPCK	68d3e88a-d1be-410b-92a1-863903b3aa61	3
2604579	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) Pack	PSN	68d3e88a-d1be-410b-92a1-863903b3aa61	3
1098496	acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet	PSN	68d3e88a-d1be-410b-92a1-863903b3aa61	3
247324	acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet	PSN	68d3e88a-d1be-410b-92a1-863903b3aa61	3
1098496	acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet	SCD	68d3e88a-d1be-410b-92a1-863903b3aa61	3
247324	acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet	SCD	68d3e88a-d1be-410b-92a1-863903b3aa61	3
2604579	1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet) / 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG Oral Tablet) Pack	SY	68d3e88a-d1be-410b-92a1-863903b3aa61	3
247324	acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet	SY	68d3e88a-d1be-410b-92a1-863903b3aa61	3
1098496	APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet	SY	68d3e88a-d1be-410b-92a1-863903b3aa61	3
247324	APAP 500 MG / Dextromethorphan Hydrobromide 15 MG Oral Tablet	SY	68d3e88a-d1be-410b-92a1-863903b3aa61	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-8161-01	00067816101	1 KIT in 1 CARTON (0067-8161-01) * 20 TABLET in 1 BLISTER PACK (0067-8162-01) * 20 TABLET in 1 BLISTER PACK (0067-8163-01)	1 kit	2022-06-27	0000-00-00	No	No	Current
0067-8162-01	00067816201	20 in 1 BLISTER PACK						Historical
0067-8163-01	00067816301	20 in 1 BLISTER PACK						Historical